Senior Scientist, Drug Product Process Development and Manufacturing

What You Will Contribute To Altos

We are seeking a highly experienced senior scientist in drug product process development and manufacturing to join the Technical Operations team within the Institute of Medicine. The candidate will work in a highly dynamic and cross-functional environment. The successful candidate will lead formulation and drug product process development and support outsourced GMP manufacturing for Altos programs. Modalities include AAV gene therapy, mRNA, and protein therapeutics.

Responsibilities

• Lead formulation and drug product process development for AAV gene therapy, mRNA-LNP, and protein therapeutics.
• Establish internal drug product process development capabilities, design and conduct experiments to develop stable and effective drug formulations, including selection of excipients, concentration optimization, and compatibility studies. Produce materials to supply non-clinical studies.
• Develop and scale-up manufacturing processes for various drug delivery systems considering critical process parameters (CPPs) and critical quality attributes (CQAs).Utilize statistical analysis and experimental design to identify and improve process parameters, maximizing product yield and quality consistency.
• Conduct stability testing to assess the long-term integrity of drug products under various storage conditions and identify potential degradation pathways.
• Manage and collaborate with CDMOs to optimize/ improve DP manufacturing processes, scale up, and establish in-process control strategies.
• Support GMP manufacturing at CDMOs, review GMP documents, troubleshoot technical issues, support deviation investigation, and lead risk assessment.
• Collaborate cross-functional with analytical development, quality control QA, Institutes of Science, development sciences, clinical, regulatory, program management, legal and finance, through lifecycle of product.
• Author, review, and/or approve development reports, regulatory filing, or other controlled documents.
• Recruit and provide direction and leadership to development associates as the team expands.
• Stay abreast of industry trends, emerging technologies, and regulatory guidelines to contribute to the continuous improvement of processes and compliances.
• Actively contribute to a team culture that promotes continuous improvement, ownership, professional growth, and inclusion.

Who You Are

Qualifications

• PhD in chemical engineering, biochemical engineering, biotechnology, or related field of biological sciences. Minimum 8+ years of cell culture process development experiences in the biotech/pharmaceutical industry.
• Proven expertise in formulation and process development for liquid and lyophilized drug products. Experiences in multiple modalities–AAV gene therapy, protein, and mRNA-LNP therapeutics, is a plus.
• Experience with new product development, formulation development, process optimization, technical transfers to CDMOs, and statistical design and analysis of experiment.
• Experiences with unit operation (i.e. filling, filtration, mixing, etc.) specific scale down model development, characterization, and scale-up.
• Understanding of physical/chemical stability of proteins and how process related stress impacts product quality.
• Experienced in achieving CMC deliverables through outsourcing to CDMOs.
• Strong problem-solving skills with ability to interpret complex data sets.
• Knowledge of regulatory requirements and quality standards related to biopharmaceutical manufacturing.
• Ability to work in a dynamic environment, with a willingness to learn new skills and adapt to shifting priorities and tasks.
• Excellent communication skills. Proven capability to collaborate effectively in a diverse, global, cross- functional structure and commit to diversity, equity, and belonging.